High Frequency Ultrasound Spring-load Front-and-side Firing Needle Transducer Developments and Pre-clinical Regional Anesthesia Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Needling time
研究概览
简要总结
To validate the efficacy of miniaturized ultrasound needle transducer as the primary guide for thoracic regional anesthesia.
详细描述
Paravertebral (PVB) and intercostal nerve block (ICNB) are both techniques of injecting local anesthetics for pain management at thoracic and upper abdominal region.
Today, PVB and ICNB are performed under the guidance of surface two dimensional B-mode ultrasound. However, the procedure still carries potential risks for inexperienced operators since the target zone is very close (2-3 mm) to the pleura. In certain patients, such as those with obesity, the steep needle trajectory and poor quality of the anatomic image make the nerve block even more difficult.
Inaccurate identification of the anatomical structures or suboptimal positioning of the needle tip could result in complications and blockade failure.
We designed an intra-needle ultrasound (INUS) system to improve the identification of anatomical structures and needle tip position. The system passed all safety standards including electrical safety test, biocompatibility test, software certification.
This study is to investigate the feasibility and image quality of INUS during ICNB and PVB. The study protocol is approved and under monitoring for safety and compliance from both Institutional Review Board of Taipei Veterans General Hospital and Ministry of Health and Welfare, Taiwan, Republic of China.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective thoracic surgery
- •Patients scheduled for elective upper abdominal surgery
- •Patients scheduled for elective breast surgeries.
排除标准
- •Known coagulopathies,
- •Skin lesion or infection at site of nerve block
- •Pregnant women
- •Allergic to local anesthetics
- •Cognitive diseases
- •Unstable hemodynamics
- •Chronic substance abuse (ex. alcohol, hypnotics, opioids)
结局指标
主要结局
Needling time
时间窗: Needle insertion to needle withdrawal, up to 20 minutes
Needle insertion to needle withdrawal (minutes)
Nerve block procedure time
时间窗: Time from ultrasound contact with skin to needle withdrawal, up to 20 minutes
How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal
Success rate of blockade
时间窗: 20 minutes post administration of local anesthetics (by ultrasound or cold sensation) or intraoperative (at the time of video-thoracoscope exploration)
Successful blockade will be determined by 1.ultrasound evidence of ideal spreading or 2.evidence of fluid accumulation around intercostal nerves or at paravertebral space under thoracoscope, or 3. loss of cold sensation on the chest or abdomen at block level.
Visibility of needle tip and anatomic structure
时间窗: During block procedure, up to 60 minutes.
Record the visibility of needle tip, intercostal muscle, superior costotransverse ligament, pleura. Assessed by the inserting anesthetist on a 5 point Likert scale
次要结局
- Inadvertent pleural puncture or pneumothorax(20 minutes post-procedure or intraoperative (if needle injuries on pleura noted by thoracoscope))